Development of regulatory strategies for medicinal products (incl. biotech products), review of documents and advice concerning meetings with authorities in Europe and United States.
Target clients: pharmaceutical companies, especially small and medium sized ones developing e.g. generic drugs which need support during the overall process of getting a medicinal products approved in various regions or on local level.
My regulatory service, including but are not limited to the following activities:
Support and review of IMPDs & INDs and other regulatory filings
Support for scientific meetings with authorities
Review of medical and technical summaries, expert reports and quality related documents
Assist regulatory procedures (Centralized, Decentralized, Mutual Recognition & NDA)